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New treatment option for Hidradenitis Suppurativa (HS)
Official title Participants with Mild to Moderate Hidradenitis Suppurativa Will Receive EVO101 a Topical Cream 0.1%
ClinicalTrials.gov ID: NCT06645821
What this study is testing
What is EVO101?
EVO101 is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for hidradenitis suppurativa (hs).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if drug EVO101 works to treat mild to moderate hidradenitis suppurativa in adults. The main questions it aims to answer are: Does drug EVO101 lower the total number of lesion a participant has from the first visit to the last visit.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ability to comprehend and willingness to sign a written informed consent form (ICF) for the study.
- Age ≥ 18 years at the time of signing the ICF (informed consent).
- Diagnosis of hidradenitis suppurativa (HS) for at least 3 months prior to the screening visit.
- Mild to moderate HS (hidradenitis suppurativa) at the Baseline Visit (using the HS-PGA/Hidradenitis Suppurativa Physician's Global Assessment scale ).
- Total hidradenitis suppurativa lesion count (abscess, fistulas, nodules, papules, and/or pustules) of at least 5 at the baseline visit.
You likely can't join if
- Very severe, severe, minimal, or clear hidradenitis suppurativa Hidradenitis Suppurativa Physician's Global Assessment scale (HS-PGA).
- Women who are pregnant (or who are considering pregnancy) or breastfeeding.
- Subject has uncontrolled, clinically significant comorbidities that make them unsuitable for the clinical trial in the opinion of the investigator.
- Have undergone significant trauma or major surgery (per investigator's assessment) within 30 days preceding the screening visit.
- History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months preceding the screening visit.
- Use of any of the following medications or treatments within the specified time periods prior to the baseline visit:
See the full eligibility criteria
- Ability to comprehend and willingness to sign a written informed consent form (ICF) for the study.
- Age ≥ 18 years at the time of signing the ICF (informed consent).
- Diagnosis of hidradenitis suppurativa (HS) for at least 3 months prior to the screening visit.
- Mild to moderate HS (hidradenitis suppurativa) at the Baseline Visit (using the HS-PGA/Hidradenitis Suppurativa Physician's Global Assessment scale ).
- Total hidradenitis suppurativa lesion count (abscess, fistulas, nodules, papules, and/or pustules) of at least 5 at the baseline visit.
- Agreement to NOT use topical and/or systemic antibiotics for treatment of HS (hidradenitis suppurativa) for the duration of the study.
- Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide. Note: Over-the-counter non-medicated soap and water is allowed.
- For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 30 days after the last...
- A woman of childbearing potential is defined as a postmenarcheal female, who has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause) and has not...
- The following are highly effective contraceptive methods: combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation, progestogen-only...
- Willing and able to comply with the study protocol and procedures.
- Very severe, severe, minimal, or clear hidradenitis suppurativa Hidradenitis Suppurativa Physician's Global Assessment scale (HS-PGA).
- Women who are pregnant (or who are considering pregnancy) or breastfeeding.
- Subject has uncontrolled, clinically significant comorbidities that make them unsuitable for the clinical trial in the opinion of the investigator.
- Have undergone significant trauma or major surgery (per investigator's assessment) within 30 days preceding the screening visit.
- History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months preceding the screening visit.
- Use of any of the following medications or treatments within the specified time periods prior to the baseline visit:
- \< 12 weeks or 5 half-lives (whichever is longer)
- Investigational or experimental treatments.
- Immunomodulating biologic drugs
- \< 4 weeks
- Systemic JAK inhibitors.
- Systemic immunosuppressive or immunomodulating small-molecule drugs (eg, corticosteroids [oral or intravenous], avacopan, IRAK4 inhibitors, methotrexate, cyclosporine, dapsone, azathioprine).
- Surgical, laser, or any phototherapy intervention in areas with HS lesions
- \< 2 weeks
- Other systemic therapies for HS
- Retinoids, antihyperglycemics, and antiandrogens, such as acitretin, isotretinoin, metformin, spironolactone, and finasteride) with potential therapeutic impact unless the subject is on a stable dose as defined by the...
- Systemic anti-infectives for HS
- Antibiotics, antivirals, antifungals
- \<1 week
- Oral or topical PDE4 inhibitor (e.g., apremilast, crisaborole)
- Topical JAK inhibitor
- Topical anti-infectives for HS lesions o Antibiotics, antivirals, antifungals
- Topical products containing chlorhexidine gluconate, benzoyl peroxide, or topical diluted bleach bath to treat HS. Note: Non-medicated over-the-counter soap and water are not restricted.
- Any topical drug applied onto HS lesions
- Topical or intralesional corticosteroids o Note: Use of topical corticosteroids for dermatologic diseases other than HS (Hidradenitis Suppurativa)(e.g., atopic dermatitis, psoriasis) is allowed for areas not being...
- Active participation in an experimental therapy study or who received experimental therapy within 30 days or 5 half-lives (whichever is longer) before Baseline.
The study team makes the final eligibility decision.
Where it's taking place
- Norfolk, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Norfolk, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.